Supporting Mental Health in Daily Life After the Diagnosis of Multiple Sclerosis

Last updated: July 24, 2024
Sponsor: Marta Bassi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Neurologic Disorders

Scar Tissue

Treatment

observational

Clinical Study ID

NCT06403631
2022/R-Multi/020
  • Ages 18-50
  • All Genders

Study Summary

The overall goal of this observational study is to learn about the psychological resources of mindfulness and flow experience available to persons newly diagnosed with multiple sclerosis (MS). The primary study aim will be to analyze the relation of flow and mindfulness with mental health among individuals who received an MS diagnosis within the last year. Secondary aims will be to analyze the daily activities preferentially associated with flow, and to evaluate possible changes in daily flow retrieval. Participants will answer questionnaires measuring flow, mindfulness, positive mental health, anxiety and depression at project start and 6 months later.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age 18-50

  • clinically-definite MS diagnosed (with McDonald's revised criteria) within theprevious 12 months

  • steroid treatment for at least 1 month

  • written informed consent

Exclusion

Exclusion Criteria:

  • neurological disorders other than MS

  • psychiatric disorders

  • severe physical impairment (EDSS=>8)

  • pregnancy

  • current or previous attendance in Mindfulness Based Interventions or Acceptance andCommitment Therapy

  • severe cognitive impairment in comprehension, attention and execution ofinferential-logical operations which could interfere with the ability to fill inquestionnaires (equivalent scores 0-1 at Progressive Raven Matrices; score <11.3 atthe visual comprehension of sentences subtest of the Aphasia NeuropsychologicalTest; score <37.9 at Symbol Digit Modalities Test; and score <93.1 at the Brief Testof Intelligence)

Study Design

Total Participants: 123
Treatment Group(s): 1
Primary Treatment: observational
Phase:
Study Start date:
November 06, 2023
Estimated Completion Date:
February 28, 2026

Study Description

The period following Multiple Sclerosis (MS) diagnosis is extremely important to identify and mobilize psychological resources that can support mental health, help cope with challenges, and lead to disease acceptance. Capitalizing on previous studies attesting to the crucial role of attentional skills in disease adjustment, the overall goal of this project is to jointly investigate flow experience and mindfulness as potential resources supporting mental health among newly diagnosed persons. While mindfulness has been widely investigated in relation to MS, flow has been rarely explored. Both constructs are rewarding mental states involving focused attention on the present moment and perceived control over the situation. Yet, they also present relevant differences. Mindfulness is characterized by reflective awareness, while flow by loss of selfconsciousness. Mindfulness can generate initial heightened unpleasant feelings, and its cultivation requires constant practice; instead, flow does not require intensive training and it is reported in association with ordinary daily situations and activities. In light of these differences, it may be suitable to promote flow, or a combination of flow and mindfulness, at the initial stages of MS, as newly diagnosed persons require immediate psychological support and need to find a sense of continuity in life. The primary study aim will be to analyze the relation of flow and mindfulness with mental health among individuals who received an MS diagnosis within the last year.

Secondary aims will be to analyze the daily activities preferentially associated with flow, and to evaluate possible changes in daily flow retrieval. Data will be gathered longitudinally from participants recruited in MS centers across Italy. Participants will fill in online questionnaires measuring flow, mindfulness, positive mental health, anxiety and depression. The questionnaires, including both scaled and open-ended questions, will be proposed at the project start (T1) and 6 months later (T2). Hierarchical regressions and qualitative analyses will be conducted to assess study aims. Both flow and mindfulness are expected to independently contribute to participants' mental health. However, considering its usual occurrence in daily contexts, flow is expected to provide a more relevant contribution than mindfulness, and to play a moderating role in the relation between mindfulness and mental health. The investigators also expect that participants will primarily retrieve flow in productive and leisure activities, and that fewer participants would find flow occasions in their daily life after the diagnosis.

Connect with a study center

  • University of Bari

    Bari,
    Italy

    Active - Recruiting

  • University of Cagliari

    Cagliari,
    Italy

    Active - Recruiting

  • University of Catania

    Catania,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Sant'Anna

    Como,
    Italy

    Active - Recruiting

  • University of Florence

    Florence,
    Italy

    Active - Recruiting

  • Università Vita-Salute San Raffaele

    Milano,
    Italy

    Active - Recruiting

  • San Luigi Gonzaga Hospital

    Orbassano,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera San Camillo Forlanini

    Roma,
    Italy

    Active - Recruiting

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